Condition category
Signs and Symptoms
Date applied
02/08/2007
Date assigned
12/09/2007
Last edited
29/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Joan Duda

ORCID ID

Contact details

School of Sport and Exercise Sciences
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 2737
jld0330@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2

Study information

Scientific title

Acronym

EMPOWER

Study hypothesis

1. To determine the effect of the present Exercise on Prescription (EoP) scheme operating in Birmingham on participants' self-reported Physical Activity (PA), associated health behaviours, physical health, and well-being/quality of life at three months and a six-month follow-up
2. To develop a Self Determination Theory-based (SDT) training program for Birmingham health and fitness advisors
3. To determine the effect of the SDT-based (EoP) scheme on participants' self-reported Physical Activity (PA) associated health behaviours, physical health, and well-being/quality of life at three months and a six-month follow-up
4. To compare the effect (at three and six months) of an exercise consultation delivered by SDT-trained health and fitness advisors with an exercise consultation provided by currently trained health and fitness advisors in Birmingham on participants' self-reported physical activity, associated health behaviours, physical health, and well-being/quality of life
5. To examine in an exploratory manner, potential differential effects of the EoP scheme where taught by SDT trained versus control health and fitness advisors as a function of the gender/age, ethnicity, and socio-economic status of the participant

Ethics approval

University of Birmingham School of Sport and Exercise Sciences Ethics Sub-Committee, 25/07/2007, ref: LE 07/22

Study design

Pragmatic cluster randomised control trial of standard exercise on prescription with a self-determination theory-based exercise on prescription

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

General population under 65 that are sedentary with risk factors, for example CHD, diabetes, high blood pressure, mild depression.

Intervention

The intervention spans a three month period during which a health and fitness advisor has one-to-one contact in person (at leisure centres) or via telephone with the participant four times. The advisors will be informed of the principles of self-determination theory and trained to employ particular strategies targeting the promotion of self-determined motivation for behavioural change in the participant.

Following the baseline assessment of the primary and secondary outcomes, the initial consultation will comprise a one hour one-to-one person centred interview and, consistent with the EoP scheme, have the option of a fitness appraisal. At this time, participants will also be given a booklet designed to encourage self-management of physical activity initiation. At one month, the next contact (15 - 20 minutes) will be conducted via telephone or face-to-face. The discussion will be reinforcing successful physical activity engagement attempts and providing strategies for enhancing exercise efficacy. At two months, a brief (5 minute) phone call or face-to-face contact by the advisor will be made to offer encouragement regarding attempts to be physically active. At three months, primary and secondary outcomes will be re-assessed and a final face-to-face "booster" consultation (20 - 30 minutes) will take place focused on recognising and reinforcing the internalisation of the participant's physical activity involvement. Again, the option of a fitness appraisal will be made available. A supplemental self-management booklet centred on the monitoring and maintenance of physical activity will also be provided at this time.

Participants in the control group will be provided with the standard EoP program.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Self-reported physical activity using the 7-day Physical Activity Recall (PAR), a structured interview that has been extensively validated against objective measures. Both estimated overall energy expenditure and time spent in vigorous and moderate intensity physical activity will be calculated for all participants at three time points (baseline, 3 months and 6 months).

Secondary outcome measures

1. Associated health behaviours: smoking, alcohol consumption, fruit/vegetable intake with brief self-report measures
2. Physical health outcomes: Body Mass Index (BMI), Blood Pressure (BP)
3. Health related quality of life using the Dartmouth Co-op Charts
4. Anxiety and depression measured by the Hospital Anxiety and Depression Scale
5. Vitality using the Subjective Vitality Scale (Ryan and Frederick)
6. Intention to increase physical activity, at baseline and three months only
7. Motivation and processes of change: perceptions of autonomy support from the Advisor, perceived efficacy, autonomy, social connectedness with respect to physical activity, and motivational regulations for exercise using validated scales (the Behavioural Regulation in Exercise Questionnaire [BREQ-2], the Health care Climate Questionnaire, Wilson’s Need Questionnaire)

All secondary outcomes measured at baseline, three months and six months (apart from point 6 above, measured at baseline and three months only).

Overall trial start date

01/09/2007

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. General population under 65 that are sedentary with risk factors, for example Coronary Heart Disease (CHD), diabetes, high blood pressure, mild depression
2. Referred by General Practitioners (GPs) to the Birmingham Exercise on Prescription Scheme

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Angina pectoris
2. Moderate to high (or unstable) hypertension: 160/102 mmHg or above
3. Poorly controlled insulin-dependant diabetes
4. History of myocardial infarction within the last six months unless the patient has completed Stage III cardiac rehabilitation
5. Established cerebro-vascular disease
6. Severe chronic obstructive airways disease
7. Uncontrolled asthma

Recruitment start date

01/09/2007

Recruitment end date

31/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Sport and Exercise Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

South Birmingham Primary Care Trust (UK)

Sponsor details

c/o Susan Stokes
Assistant Director of Public Health
Moseley Hall Hospital
Alcester Road
Moseley
Birmingham
B13 8JL
United Kingdom

Sponsor type

Government

Website

http://www.southbirminghampct.nhs.uk/

Funders

Funder type

Government

Funder name

Heart of Birmingham Teaching Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Birmingham East and North Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South Birmingham Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Birmingham City Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Birmingham Health and Wellbeing Partnership (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19505293
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24475766

Publication citations

  1. Protocol

    Jolly K, Duda JL, Daley A, Eves FF, Mutrie N, Ntoumanis N, Rouse PC, Lodhia R, Williams GC, Evaluation of a standard provision versus an autonomy promotive exercise referral programme: rationale and study design., BMC Public Health, 2009, 9, 176, doi: 10.1186/1471-2458-9-176.

  2. Results

    Duda JL, Williams GC, Ntoumanis N, Daley A, Eves FF, Mutrie N, Rouse PC, Lodhia R, Blamey RV, Jolly K, Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial., Int J Behav Nutr Phys Act, 2014, 11, 10, doi: 10.1186/1479-5868-11-10.

Additional files

Editorial Notes